First-Line Nivolumab Plus Ipilimumab in Unresectable Hepatocellular Carcinoma (J-PROMISE)

Prospective Observational Study of First-Line Nivolumab Plus Ipilimumab in Patients With Unresectable Hepatocellular Carcinoma in Japan (J-PROMISE)

This study looks at how a combination of two medicines, nivolumab and ipilimumab, is used to treat people with advanced liver cancer that cannot be removed by surgery. The study will follow adults receiving this treatment in routine medical care in Japan to understand how safe it is, how well it works, and how it is used in standard clinical practice.

Inclusion Criteria:

• Participants aged ≥ 18 years at the time of consent

• Participants with unresectable hepatocellular carcinoma (uHCC), defined as disease not eligible for curative surgical and/or locoregional therapies, or progressive disease after surgical and/or locoregional therapies

• Child-Pugh class A (total score 5-6)

• Participants who have not received prior systemic drug therapy for uHCC

  • Participants who relapsed more than 6 months after completion of postoperative adjuvant therapy are eligible
  • Participants who received lenvatinib in combination with transarterial chemoembolization (TACE) are eligible if the treating physician determined they were eligible for TACE; participants are excluded if TACE eligibility at the time of lenvatinib initiation is unclear

• Participants scheduled to initiate nivolumab plus ipilimumab combination therapy between March 1, 2026 and February 28, 2027

  • Nivolumab plus ipilimumab combination therapy is defined as nivolumab 80 mg and ipilimumab 3 mg/kg administered intravenously every 3 weeks for 4 cycles, followed by nivolumab monotherapy at 240 mg every 2 weeks or 480 mg every 4 weeks

• Participants who provide written informed consent prior to initiation of nivolumab plus ipilimumab therapy

Exclusion Criteria:

• Known fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, or mixed cholangiocarcinoma
• Prior liver transplant
• ECOG performance status ≥ 3
• Uncontrolled comorbidities despite treatment
• Other advanced cancers requiring systemic therapy
• Prior immuno-oncology treatment
• Participation in interventional clinical trials at enrollment
• Deemed unsuitable by investigator